Avandia, Seroquel top adverse-event reports

An account of adverse event reports during 2009's third quarter shows that No. 1 on the list for the most AEs was GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) with 1,218 reports--1,000 of which were serious or fatal. Avandia was recently cited in a U.S. Senate report, touching off a public argument over the drug's safety and Glaxo's conduct.

Second in line was AstraZeneca's antipsychotic drug Seroquel (quetiapine), with 977 reports; third came Novartis' Lioresal (baclofen) with 796. Rounding out the top five: The pain drug fentanyl with 688, and Amgen and Pfizer's rheumatoid arthritis and psoriasis treatment Enbrel (etanercept) with 495.

This ranking comes from the Institute for Safe Medication Practices and includes reports from a variety of sources. The institute tracks adverse reporting for almost 2,000 drugs, the vast majority of which saw very few. Fifty-seven drugs had 100 or more AEs reported during the quarter.

You'll note that this report of Avandia's AEs comes as debate heats up on the drug's safety. The Seroquel AE reports came in as AstraZeneca fought legal battles with plaintiffs alleging that the drug caused their diabetes. Both companies told the institute that the high number of reports probably stemmed from ongoing litigation over the drugs, and it's true that in the past, some drugs saw AE reports rise markedly after safety problems hit the news.

- read the Pharmalot post
- see the institute's report